FDA product code GXN: Plate, Cranioplasty, Preformed, Non-Alterable
GXN is the FDA product code for plate, cranioplasty, preformed, non-alterable. It is a Class II device, regulated under 21 CFR 882.5330 and reviewed by the Neurology panel. FDA has cleared 57 510(k) submissions under GXN, 10 in the last five years, from 30 different applicants. The average 510(k) review took 155 days (median 102); 145 days on average over the last three years. FDA has posted 11 recalls for GXN devices.
Classification
| Field | Value |
|---|---|
| Device name | Plate, Cranioplasty, Preformed, Non-Alterable |
| Device class | Class II |
| Regulation | 21 CFR 882.5330 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for GXN
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 188 |
| 2018 | 3 | 227 |
| 2020 | 5 | 139 |
| 2021 | 3 | 147 |
| 2022 | 2 | 251 |
| 2023 | 1 | 133 |
| 2024 | 1 | 28 |
| 2025 | 2 | 216 |
| 2026 | 4 | 191 |
Compare with all 510(k) review times · Search every GXN clearance
Top GXN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Longeviti Neuro Solutions, LLC | 7 | 2023-11-09 |
| Fin-Ceramica Faenza S.P.A. | 5 | 2024-03-28 |
| Bioplate, Inc. | 5 | 2008-08-13 |
| Synthes (Usa) | 4 | 2005-12-14 |
| KLS-Martin L.P. | 3 | 2025-11-10 |
25 more applicants have GXN clearances. See the full list in Caduvo.
Most recent GXN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260709 | Longeviti Neuro Solutions | ClearFit Ti Ring 14mm (171750);ClearFit Ti Ring 14mm with Slot (171751);ClearFit Ti Ring 20mm (171752);ClearFit Ti Ring 20mm with Slot (171753);ClearFit Ti Ring 30mm (171754) | 2026-06-25 | 113 |
| K253116 | The Surgeon General, Department of the Army (TSG-DA) | 3D MAC Titanium Cranial Plate (TCP) System | 2026-06-18 | 267 |
| K252251 | CG Bio Co., Ltd. | EASYMADE-TI | 2026-04-09 | 265 |
| K252958 | Meticuly Co., Ltd. | METICULY Patient-specific titanium mesh implant | 2026-01-14 | 120 |
| K243715 | Synthes GmbH | Synthes Patient Specific Implants | 2025-11-12 | 345 |
Recalls for GXN devices
11 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-08-22.
| Year | Recalls |
|---|---|
| 2017 | 4 |
| 2018 | 6 |
Frequently asked questions
What is FDA product code GXN?
GXN is the FDA product code for plate, cranioplasty, preformed, non-alterable. It is a Class II device, regulated under 21 CFR 882.5330 and reviewed by the Neurology panel.
What device class is GXN?
Class II, regulation 21 CFR 882.5330. Typical premarket route: 510(k).
How long does a 510(k) take for product code GXN?
Across 57 cleared submissions the average was 155 days from receipt to decision (median 102).
Which companies have the most GXN clearances?
Longeviti Neuro Solutions, LLC (7); Fin-Ceramica Faenza S.P.A. (5); Bioplate, Inc. (5); Synthes (Usa) (4); KLS-Martin L.P. (3).
Have GXN devices been recalled?
Yes: 11 product recalls across 3 recall events; the most recent began 2018-08-22.
Next steps
- Run an FDA pathway report with predicate devices for product code GXN
- Run a recall and safety report across every GXN manufacturer
- Watch product code GXN for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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